K Number
K240512
Device Name
Tixel i (TXLI0001)
Manufacturer
Date Cleared
2024-11-04

(256 days)

Product Code
Regulation Number
886.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).
Device Description
The Tixel i is intended to deliver heat and pressure to the eyelids of patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD). The Tixel i is comprised of a Console, which is connected via an umbilical tube to an applicator, referred to as "Handpiece." The Handpiece includes a therapeutic element, the "Tip," fixated on its distal end. A clear polycarbonate illuminated Distance Gauge, mounted on the distal end of the Handpiece, covers the Tip and allows proper and safe positioning of the Handpiece on the skin prior to performing a treatment pulse. The Distance Gauge is removed only when the Tip is being cleaned. The Tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. The active surface of the Tip consists of an array of 24 (6×4) square-based pyramids, evenly spaced. The pyramids have a blunt apex to allow effective heat transfer and prevent any risk of mechanical puncturing of the skin. The backplane of the Tip attaches to a ceramic heater that maintains a constant temperature during operation. During a Tixel i procedure, an Aestek plastic ocular shield (Oculo-Plastik, Inc.) is to be inserted under the eyelids on the ocular surface to protect the eye during the procedure.
More Information

No
The summary describes a device that applies heat and pressure. There is no mention of AI, ML, image processing, or any data-driven decision-making process within the device's operation.

Yes
The device is indicated for "application of localized heat and pressure therapy" to treat evaporative dry eye disease due to MGD, and its performance studies measure "improvement in tear break-up time, dry eye symptoms as measured by the OSDI, and meibomian gland scores," all of which demonstrate a therapeutic effect.

No

The Tixel i is indicated for applying localized heat and pressure therapy to treat dry eye disease. It is a therapeutic device, not a diagnostic one.

No

The device description clearly outlines physical hardware components including a Console, Handpiece, Tip, and Distance Gauge, which are integral to the device's function of delivering heat and pressure.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for applying localized heat and pressure therapy to treat dry eye disease due to MGD. This is a therapeutic treatment applied directly to the patient's body.
  • Device Description: The device description details a system that delivers heat and pressure to the eyelids. This is a physical intervention, not a test performed on a sample taken from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

Product codes

ORZ

Device Description

The Tixel i is intended to deliver heat and pressure to the eyelids of patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD). The Tixel i is comprised of a Console, which is connected via an umbilical tube to an applicator, referred to as "Handpiece."

The Handpiece includes a therapeutic element, the "Tip," fixated on its distal end. A clear polycarbonate illuminated Distance Gauge, mounted on the distal end of the Handpiece, covers the Tip and allows proper and safe positioning of the Handpiece on the skin prior to performing a treatment pulse. The Distance Gauge is removed only when the Tip is being cleaned.

The Tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. The active surface of the Tip consists of an array of 24 (6×4) square-based pyramids, evenly spaced. The pyramids have a blunt apex to allow effective heat transfer and prevent any risk of mechanical puncturing of the skin. The backplane of the Tip attaches to a ceramic heater that maintains a constant temperature during operation.

During a Tixel i procedure, an Aestek plastic ocular shield (Oculo-Plastik, Inc.) is to be inserted under the eyelids on the ocular surface to protect the eye during the procedure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eyelids

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Eyecare professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

A prospective, multi-center, randomized, controlled, pivotal trial was conducted to evaluate the safety and effectiveness of the Tixel device compared to the LipiFlow device. The study was conducted at 5 centers in the United States between September 2022 and June 2023.

Sample Size: A total of 109 subjects were enrolled and randomized, 54 to Tixel and 55 to LipiFlow.

Key Results:
Primary effectiveness endpoint: The change from baseline to 4 weeks in TBUT.
Tixel subjects had a mean baseline TBUT of 4.3 ± 1.5 seconds compared with 4.6 ± 1.8 seconds for the LipiFlow group.
Tixel subjects had a mean (±SE) improvement in TBUT of 3.0 ± 0.4 seconds compared with 2.8 ± 0.4 seconds for LipiFlow.
The difference in mean (± SE) improvement in TBUT at 1 month between LipiFlow and Tixel was -0.17 ± 0.55 seconds. Tixel was non-inferior to LipiFlow for the improvement in TBUT at 1 month (upper bound of one-sided 95% Cl of 0.73; p

§ 886.5200 Eyelid thermal pulsation system.

(a)
Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;
(2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions;
(3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components;
(4) The device should be demonstrated to be biocompatible; and
(5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 4, 2024

Novoxel Ltd. Anne-Marie Ripley Clinical & Regulatory Affairs Consultant Regulatory Pathways Group, Inc. 440 N. Barranca Ave #2471 Covina, CA 91723

Re: K240512

Trade/Device Name: Tixel i (TXLI0001) Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ Dated: September 26, 2024 Received: September 26, 2024

Dear Anne-Marie Ripley:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

2

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J Angelo Green -S

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Exp
Se

Submission Number (if known)

K240512

Device Name

Tixel i (TXLI0001)

Indications for Use (Describe)

The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K240512

l. Submitter Information

  • 510(k) Owner: Novoxel Ltd. 43 Hamelaha St. Netanya, Israel 4250573 +972 9 7739074
  • Contact Person: Daniela Dov Elmaz daniela@novoxel.com
  • Date Prepared: October 24, 2024

II. Device Name and Classification

  • Device Trade Name: Tixel i (TXLI0001)
  • Common Name: Evelid thermal pulsation system
  • Regulation Number: 21 CFR 886.5200
  • Device Classification: Class 2
  • ORZ Product Code:

lll. Predicate Device and Reference Devices

Predicate Devices

  • . LipiFlow Thermal Pulsation System by TearScience (K192623) - Primary Predicate
  • iLux by Tear Film Innovation (K172645) ●
  • TearCare MGX by Sight Sciences (K231084)

Reference Device

  • . Tixel C by Novoxel (K223033)
    The Tixel C supports the methods (i.e., an ex vivo study) used to demonstrate the safety of the heat and pressure delivered by the Tixel i to the target tissue. In addition, many of the bench tests performed on the Tixel C are applicable to the Tixel i as only minor modifications have been made to the Tixel C to create the Tixel i.

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IV. Device Description

The Tixel i is intended to deliver heat and pressure to the eyelids of patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD). The Tixel i is comprised of a Console, which is connected via an umbilical tube to an applicator, referred to as "Handpiece."

The Handpiece includes a therapeutic element, the "Tip," fixated on its distal end. A clear polycarbonate illuminated Distance Gauge, mounted on the distal end of the Handpiece, covers the Tip and allows proper and safe positioning of the Handpiece on the skin prior to performing a treatment pulse. The Distance Gauge is removed only when the Tip is being cleaned.

The Tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. The active surface of the Tip consists of an array of 24 (6×4) square-based pyramids, evenly spaced. The pyramids have a blunt apex to allow effective heat transfer and prevent any risk of mechanical puncturing of the skin. The backplane of the Tip attaches to a ceramic heater that maintains a constant temperature during operation.

During a Tixel i procedure, an Aestek plastic ocular shield (Oculo-Plastik, Inc.) is to be inserted under the eyelids on the ocular surface to protect the eye during the procedure.

V. Indications for Use

The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

VI. Comparison of Technological Characteristics with the Predicate Devices

Although the Tixel i device and the predicate devices do not share identical technological characteristics, these differences do not raise different types of questions of safety and effectiveness.

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| Characteristic | Subject Device
Tixel i
Novoxel, Ltd.
K240512 | Primary Predicate
LipiFlow® Thermal
Pulsation System
TearScience
(now Johnson & Johnson)
K192623 | Predicate 2
iLux
Tear Film Innovation
(now Alcon)
K172645 | Predicate 3
TearCare MGX
Sight Sciences, Inc.
K231084 | Comparison of Subject Device to Predicate
Devices |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | 2 | 2 | 2 | 2 | |
| Product Code | ORZ | ORZ | ORZ | ORZ | Same |
| Regulation Number | 886.5200 | 886.5200 | 886.5200 | 886.5200 | Same |
| Intended Use | Application of localized heat
and pressure therapy to the
eyelids | Application of localized heat
and pressure therapy to the
eyelids | Application of localized heat
and pressure therapy to the
eyelids | Application of localized heat
and pressure therapy to the
eyelids | Same |
| Indication for Use | The Tixel i is indicated for
the application of localized
heat and pressure therapy
in adult patients with
evaporative dry eye disease
due to meibomian gland
dysfunction (MGD). | The LipiFlow® Thermal
Pulsation System is
intended for the application
of localized heat and
pressure therapy in adult
patients with chronic cystic
conditions of the eyelids,
including meibomian gland
dysfunction (MGD), also
known as evaporative dry
eye or lipid deficiency dry
eve | The iLux System is indicated
for the application of
localized heat and pressure
therapy in adult patients
with chronic diseases of the
eyelids, including
meibomian gland
dysfunction (MGD), also
known as evaporative dry
eye. | The TearCare® MGX System
is intended for the
application of localized heat
therapy in adult patients
with evaporative dry eye
disease due to meibomian
gland dysfunction (MGD),
when used in conjunction
with manual expression of
the meibomian glands. | Similar |
| Characteristic | Subject Device
Tixel i
Novoxel, Ltd.
K240512 | Primary Predicate
LipiFlow® Thermal
Pulsation System
TearScience
(now Johnson & Johnson)
K192623 | Predicate 2
iLux
Tear Film Innovation
(now Alcon)
K172645 | Predicate 3
TearCare MGX
Sight Sciences, Inc.
K231084 | Comparison of Subject Device to Predicate
Devices |
| Device Description | System is comprised of a
Console which is connected
via a cord to an applicator
("Handpiece"). The tip of
the Handpiece delivers heat
and pressure to the outer
surface of the eyelid. | System is comprised of a
control unit which is
connected via a cord to an
Activator. The Activator has
a combined Eye Cup and Lid
Warmer. The Eye Cup
contacts the outer eyelid
and applies pressure to the
eyelids. The Lid Warmer
contacts the inner eyelid
and applies unidirectional
heat to the inner surface of
the eyelid. | Handheld instrument that is
coupled to a Disposable
component that is
positioned between the
eyelid and the globe. The
iLux System delivers heat
and pressure to the outer
surface of the eyelid. | • SmartLids are attached to
the outer surface of the
eyelids and connect to the
SmartHub controller which
generates the heat that is
delivered to the eyelids.
• A separate Clearance
Assistant is used in
conjunction with TearCare
to perform manual
expression of the
meibomian glands
immediately following
heat treatment with
TearCare. | Similar |
| Single Use or
Reusable | Both the Console and
Handpiece are reusable | • Control Unit: reusable
• Applicator: single use | • Handheld instrument:
reusable
• Disposable: single use | • SmartHub: reusable
• SmartLid: single use | · Console/Control unit/handheld: Same. All
are reusable.
• Eyelid-contacting component: Different.
The difference in reusability of the eyelid-
contacting component does not raise
different types of questions of safety and
effectiveness.
The Tixel i only contacts the outer eyelid
surface. It includes the same handpiece
and similar cleaning/disinfection
instructions as the Reference Device. The |
| Characteristic | Subject Device
Tixel i
Novoxel, Ltd.
K240512 | Primary Predicate
LipiFlow® Thermal
Pulsation System
TearScience
(now Johnson & Johnson)
K192623 | Predicate 2
iLux
Tear Film Innovation
(now Alcon)
K172645 | Predicate 3
TearCare MGX
Sight Sciences, Inc.
K231084 | Comparison of Subject Device to Predicate
Devices |
| Provided Sterile? | No. Device only contacts
the outer eyelid surface.
The device is provided non-
sterile and is cleaned and
disinfected by the user
before each use. | Yes. The Applicator
contacts the cornea and
inner eyelid and is thus
provided sterile. | Yes. The Disposable
contacts the cornea and
inner eyelid and is thus
provided sterile. | No. SmartLids only contact
the outer eyelid surface and
are thus provided non-
sterile. | Similar to Predicate 3, which is provided non-
sterile.
The Tixel i has the same handpiece and similar
cleaning/disinfection instructions as the
Reference Device. The Reference Device
supports the bench testing methods used to
demonstrate the effectiveness of these
procedures. |
| Device Operation | Eyecare professional
operates handpiece to
perform the procedure. | Eye care professional places
Applicators in the eye, then
starts the procedure. No
handheld instrument is used
to perform the procedure. | Eyecare professional
operates handpiece to
perform the procedure. | Eyecare professional applies
SmartLids to the outer
eyelid surface, connects the
SmartLids to the SmartHub,
then starts the procedure.
After the warming
procedure is complete, the
ECP performs manual
expression of the eyelids. | Similar to Predicate 2. |
| Tissue to which heat
is directly applied | Outer eyelid surface | Inner eyelid surface
(palpebral conjunctiva) | Outer eyelid surface | Outer eyelid surface | Same as Predicates 2 and 3 |
| Characteristic | Subject Device | Primary Predicate | Predicate 2 | Predicate 3 | Comparison of Subject Device to Predicate
Devices |
| | Tixel i
Novoxel, Ltd.
K240512 | LipiFlow® Thermal
Pulsation System
TearScience
(now Johnson & Johnson)
K192623 | iLux
Tear Film Innovation
(now Alcon)
K172645 | TearCare MGX
Sight Sciences, Inc.
K231084 | |
| Heat Delivery Method | • High heat for extremely
short duration
• 385 - 405° C for 6 ms per
pulse
• 10 pulses per eyelid, 40
pulses per procedure
• Total contact time
between the tip and the
outer eyelid is 60 ms per
eyelid. | • Low heat for long
duration
• 40 - 43°C for 12 minutes | • Low heat for long
duration
• 38 - 44° C for
approximately 8-12
minutes | • Low heat for long duration
• 41 - 45° C for 15 minutes | Different, but difference does not raise
different types of questions of safety or
effectiveness.
• Worst-case ex vivo testing, bench testing,
and a computational analysis were used
together to support the thermal safety of
the Tixel i.
• Like the predicate devices, the Tixel i
underwent clinical validation in a
randomized, controlled pivotal trial to
demonstrate the safety and effectiveness
for the intended use.
• In addition, the Tixel i delivers the same
temperature and pulse duration as the
Reference device.
• The Primary Predicate, Predicate 3 and
Reference Device support the ex vivo
testing methods used to demonstrate the
safety and effectiveness of this
technological feature. |
| Characteristic | Subject Device | Primary Predicate | Predicate 2 | Predicate 3 | Comparison of Subject Device to Predicate Devices |
| | Tixel i
Novoxel, Ltd.
K240512 | LipiFlow® Thermal
Pulsation System
TearScience
(now Johnson & Johnson)
K192623 | iLux
Tear Film Innovation
(now Alcon)
K172645 | TearCare MGX
Sight Sciences, Inc.
K231084 | |
| Heat source | Ceramic heater within
metallic housing conducts
heat to an array of titanium-
covered blunt-tipped
pyramids | Resistive (plastic) electric
heater | LEDs (lime-green and IR
wavelengths) | Polymer encapsulated
resistive heating element | Different, but difference does not raise
different types of questions of safety or
effectiveness. Heat source is the same as the
Reference Device. The Primary Predicate,
Predicate 3 and Reference Device support the
ex vivo testing methods used to demonstrate
the safety and effectiveness of this
technological feature.

Like the predicate devices, the Tixel i
underwent clinical validation in a randomized
controlled pivotal trial to demonstrate the
safety and effectiveness for the intended use. |
| Pressure Control | Automatic: Pre-
programmed based on the
protrusion depth. | Automatic: Pre-
programmed with some
adjustment allowed by the
eye care professional | Manual: Eye care
professional determines
(based on patient feedback
and direct viewing of
glands) | Manual: Eye care
professional performs
manual expression. | Similar to Primary Predicate |
| Pressure Type | Compression | Massage | Compression | Compression | Similar to Predicates 2 and 3 |
| Treatment of upper
and lower eyelids | Sequential | Concurrent | Sequential | Heat delivery: Concurrent
Manual expression:
Sequential | Similar to Predicates 2 and 3 |
| Software | Yes | Yes | Yes | Yes | Same |
| Power Source | AC-powered | AC-powered | Batteries, DC power | Batteries, DC power | Same as Primary Predicate |
| Safety per
IEC 60601-1 & -2 | Meets requirements | Meets requirements | Meets requirements | Meets requirements | Same |

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Summary of Non-Clinical Testing VII.

Based on the risk assessment, design control requirements, and an assessment of the changes between the reference Tixel C device and the Tixel i, the following verification and validation testing was performed on the Tixel i:

  • Electromagnetic compatibility (EMC) was conducted per:
    • IEC 60601-1-2:2020 Medical electrical equipment Part 1-2: General requirements for safety and essential performance – Collateral Standard: Electromagnetic compatibility - Requirements and tests
    • IEC 60601-4-2: 2016 Medical electrical equipment Part 4-2: Guidance and o interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
  • . Electrical safety testing was conducted per IEC 60601-1:2020 Medical electrical equipment – Part 1: General requirements for safety 1: collateral standard: Safety Requirements for Medical Electrical Systems.
  • Human factors testing was conducted per
    • FDA guidance, "Applying Human Factors and Usability Engineering to Medical O Devices"
    • o IEC 62366-1:2020 Medical devices Part 1: Application of usability engineering to medical devices, and
    • IEC 60601-1-6:2020 Medical electrical equipment Part 1-6: General o requirements for basic safety and essential performance – Collateral standard: Usability
  • . Ex Vivo Testing: Novoxel performed an ex vivo study, applying worst-case assumptions, to assess the thermal and mechanical effects of the Tixel i device. This study was conducted in ex vivo Yucatan pig eyelid specimens. The ex vivo study demonstrated that the Tixel i met the acceptance criteria with respect to inner eyelid temperature, pressure on the globe, and acute histopathological observations in the eyelids tissue.
  • . Bench Testing: Novoxel performed bench testing, applying worst-case assumptions, to assess the effect of Tixel i pulses accidentally being delivered directly to the ocular shield. This testing demonstrated that the ocular shield remains intact and maintains its structural integrity after exposure to several Tixel i pulses. NOTE: Ocular shields were not placed during the pivotal clinical study and no injury to the ocular surface was reported in the study. However, as a conservative measure it was determined that ocular shields should be used as part of the Tixel i procedure to mitigate risk to the ocular surface. Only the Aestek plastic ocular shield (Oculo-Plastik, Inc.) was evaluated in the bench testing and the computational analysis described in the next bullet.
  • . Computational Analysis: Novoxel performed a computational analysis which demonstrated that the plastic ocular shield protects the ocular surface from thermal exposure in the unlikely event that Tixel i pulses are accidentally delivered directly to

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the ocular shield. This analysis was conducted per specifications in IEC 60601-1:2020 using worst-case assumptions.

  • . Software verification and validation testing were conducted, and documentation was provided as recommended by FDA Guidance for the Content of Premarket Submissions for Software Device Software Functions, June 2023. The software was found to fit in the category of products that would require Basic Documentation Level because the failure or latent flaw of the device software function would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device or others in the environment of use prior to the implementation of the risk controls.
    Results of the non-clinical testing support a substantial equivalence determination. The Tixel i device is substantially equivalent to its predicate devices for the indications for use.

VIII. Clinical Performance Testing

A prospective, multi-center, randomized, controlled, pivotal trial was conducted to evaluate the safety and effectiveness of the Tixel device compared to the LipiFlow device (one of the predicate devices). The study was conducted at 5 centers in the United States between September 2022 and June 2023.

Methods

The primary effectiveness endpoint of the study was the change from baseline to 4 weeks in TBUT.

Secondary effectiveness endpoints were:

  • The change from baseline to 4 weeks and 12 weeks in the OSDI score,
  • The change from baseline to 4-weeks and 12-weeks in the MGS, and
  • . The change from baseline to 12-weeks in TBUT.

The key safety endpoint was the rate of ocular adverse events. Secondary safety endpoints included evaluation of pain and discomfort during treatment, ocular surface staining, intraocular pressure, and best corrected distance visual acuity.

The study was designed to include adult subjects with symptoms of dry eye disease and MGD. Subjects were required to be 22 years or older who reported dry eye symptoms for 3 months prior to the study. They were required to have an Ocular Surface Disease Index (OSDI) score between 23-79, a tear break-up time (TBUT)